Trial record 1 of 1 for:    NCT00692770
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Sorafenib as Adjuvant Treatment in the Prevention Of Recurrence of Hepatocellular Carcinoma (STORM)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00692770
First received: June 5, 2008
Last updated: September 11, 2014
Last verified: September 2014
  Purpose

To evaluate efficacy and safety of sorafenib versus placebo in the adjuvant treatment of Hepatocellular Carcinoma (HCC) after potentially curative treatment (surgical resection or local ablation).


Condition Intervention Phase
Carcinoma, Hepatocellular
Drug: Nexavar (Sorafenib, BAY43-9006)
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase III Randomized, Double-blind, Placebo-controlled Study of Sorafenib as Adjuvant Treatment for Hepatocellular Carcinoma After Surgical Resection or Local Ablation.

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Recurrence Free Survival [ Time Frame: approximately 70 months from first patient first visit ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to recurrence [ Time Frame: approximately 70 months from first patient first visit ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: approximately 140 months from first patient first visit ] [ Designated as safety issue: No ]
  • Patient-Reported Outcome (PRO) as assessed by FACT-Hep and EQ-5D questionnaire. [ Time Frame: approximately 70 months from first patient first visit ] [ Designated as safety issue: No ]
  • Evaluation of biomarkers. [ Time Frame: approximately 70 months from first patient first visit ] [ Designated as safety issue: No ]

Enrollment: 1114
Study Start Date: August 2008
Estimated Study Completion Date: December 2014
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: Nexavar (Sorafenib, BAY43-9006)
400mg (2 x 200mg tablets) orally, twice a day, continuously , until disease recurrence or unacceptable toxicity or other criteria for withdrawal are met.
Placebo Comparator: Arm 2 Drug: Placebo
400mg (2 x 200mg tablets) orally, twice a day, continuously , until disease recurrence or unacceptable toxicity or other criteria for withdrawal are met.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects who have undergone surgical resection or local ablation (PEI or percutaneous or intraoperative RFA) for treatment of HCC with curative intent within 4 months from staging to potentially curative treatment. A maximum of 2 local ablation courses may be administered during this time period.
  • At least 3 weeks (21 days) but no more than 7 weeks (49 days), from resection or last local ablation course, to CT/MRI scan date
  • Male or female subjects >/= 18 years of age
  • Confirmation of CR (absence of residual tumor after curative treatment), on the eligibility scan by independent radiological review.
  • For subjects undergoing surgical resection pathology proven complete removal of tumor.
  • Intermediate or High Risk of recurrence as assessed by tumor characteristics.
  • Child-Pugh score 5 -7 points. A Child-Pugh score of 7 points is allowed only in the absence of ascites.
  • ECOG Performance Status of 0.
  • Adequate bone marrow, liver and renal function

Exclusion Criteria:

  • Recurrent HCC
  • Child-Pugh score 7 points with presence of ascites.
  • Low risk of recurrence after curative treatment
  • History of cardiovascular disease
  • History of HIV infection
  • Active clinically serious infections (> grade 2 NCI-CTCAE version 3.0)
  • Subjects with seizure disorder requiring medication (such as steroids or anti-epileptics)
  • Subjects with evidence or history of bleeding diathesis
  • Subjects undergoing renal dialysis
  • Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors [Ta, Tis & T1] or any cancer curatively treated > 3 years prior to study entry as defined by the signing of informed consent..
  • Uncontrolled ascites (defined as not easily controlled with diuretic treatment)
  • Encephalopathy
  • History of GI bleeding within 30 days of randomization.
  • Subjects with a history of esophageal varices bleeding which has not been followed by effective therapy and/or treatment to prevent bleeding recurrence.
  • Prior anti cancer therapy for treatment of HCC (including sorafenib or any other molecular therapy) is excluded.
  • Major surgery within 4 weeks of start of study as defined by the signing of informed consent, except for surgical resection or local ablation of HCC.
  • Investigational drug therapy outside of this trial during or within 4 weeks of study entry, as defined by the signing of informed consent.
  • Liver transplantation, this includes patients on a transplant list with the intention to transplant
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00692770

  Hide Study Locations
Locations
United States, Alabama
Birmingham, Alabama, United States, 35294-3300
United States, Arizona
Phoenix, Arizona, United States, 85054
United States, California
La Jolla, California, United States, 92093-0987
Los Angeles, California, United States, 90095-7077
Los Angeles, California, United States, 90033
San Francisco, California, United States, 94115
United States, District of Columbia
Washington, District of Columbia, United States, 20007
United States, Florida
Miami, Florida, United States, 33136
United States, Georgia
Atlanta, Georgia, United States, 30309-1231
Atlanta, Georgia, United States, 30322
United States, Indiana
Indianapolis, Indiana, United States, 46202
United States, Kansas
Kansas City, Kansas, United States, 66160
United States, Kentucky
Louisville, Kentucky, United States, 40202
United States, Louisiana
New Orleans, Louisiana, United States, 70112
United States, Maryland
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Boston, Massachusetts, United States, 02114
Boston, Massachusetts, United States, 02215
Burlington, Massachusetts, United States, 01805
United States, Michigan
Ann Arbor, Michigan, United States, 48109
United States, Minnesota
Minneapolis, Minnesota, United States, 55455
Minneapolis, Minnesota, United States, 55407
United States, New York
New York, New York, United States, 10029
United States, Ohio
Cleveland, Ohio, United States, 44195
Cleveland, Ohio, United States, 44106
Columbus, Ohio, United States, 43210
United States, Oregon
Portland, Oregon, United States, 97239
Portland, Oregon, United States, 97213
United States, Pennsylvania
Pittsburgh, Pennsylvania, United States, 15213
United States, Texas
Houston, Texas, United States, 77030
United States, Virginia
Richmond, Virginia, United States, 23249
United States, Washington
Seattle, Washington, United States, 98109
Seattle, Washington, United States, 98101
United States, Wisconsin
Madison, Wisconsin, United States, 53791-6164
Argentina
Pilar, Buenos Aires, Argentina, B1629ODT
Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina, C1118AAT
Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina, C1280AEB
Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina, C1181ACH
Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina, C1093AAS
Guaymallen, Mendoza, Argentina, M5519GLU
Rosario, Santa Fe, Argentina, S2002KDS
Australia, New South Wales
Camperdown, New South Wales, Australia, 2050
Randwick, New South Wales, Australia, 2031
St Leonards, New South Wales, Australia, 2065
Australia, Queensland
Brisbane, Queensland, Australia, 4120
Australia, Victoria
Heidelberg, Victoria, Australia, 3084
Melbourne, Victoria, Australia, 3004
Austria
Innsbruck, Austria, 6020
Linz, Austria, 4020
Salzburg, Austria, 5020
Wien, Austria, 1090
Belgium
Bruxelles - Brussel, Belgium, 1200
Gent, Belgium, 9000
Leuven, Belgium, 3000
Liege, Belgium, 4000
Brazil
Porto Alegre, Rio Grande do Sul, Brazil, 90035-903
Porto Alegre, Rio Grande do Sul, Brazil, 90610-000
Porto Alegre, Rio Grande do Sul, Brazil, 90470 340
São Paulo, Sao Paulo, Brazil, 01323-001
Belo Horizonte, Brazil, 30380490
Sao Paulo, Brazil, 01246-903
Bulgaria
Plovdiv, Bulgaria, 4002
Sofia, Bulgaria, 1784
Sofia, Bulgaria, 1606
Varna, Bulgaria, 9002
Canada, Alberta
Calgary, Alberta, Canada, T2N 4N1
Edmonton, Alberta, Canada, T6G 1Z2
Canada, British Columbia
Vancouver, British Columbia, Canada, V5Z 4E6
Canada, Nova Scotia
Halifax, Nova Scotia, Canada, B3H 2Y9
Canada, Ontario
Ottawa, Ontario, Canada, K1H 8L6
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
Montreal, Quebec, Canada, H3A 1A1
Chile
Santiago de Chile, Santiago, Chile, 833-0024
Reñaca, Valparaíso, Chile
Santiago, Chile, 838-0456
Valparaiso, Chile, 2363058
China, Guangdong
Guangzhou, Guangdong, China, 510080
Guangzhou, Guangdong, China, 510515
Guangzhou, Guangdong, China, 510060
China, Guangxi
Nanning, Guangxi, China, 530021
China, Hubei
Wuhan, Hubei, China, 430022
China, Hunan
Changsha, Hunan, China, 410013
Changsha, Hunan, China, 410008
China, Jiangsu
Nanjing, Jiangsu, China, 210002
China, Shanxi
Xi'an, Shanxi, China, 710038
Xi'an, Shanxi, China, 710068
Xi'an, Shanxi, China, 710061
China, Sichuan
Chengdu, Sichuan, China, 610072
Chengdu, Sichuan, China, 610041
China, Zhejiang
Hangzhou, Zhejiang, China, 310022
China
Beijing, China, 100853
Beijing, China, 100021
Beijing, China, 100071
Beijing, China, 100142
Beijng, China, 100142
Chongqing, China, 400038
Dalian, China, 116027
Hefei, China, 230022
Shanghai, China, 200438
Shanghai, China, 200032
Shanghai, China, 200001
Tianjin, China, 300060
France
ANGERS cedex 09, France, 49933
Bondy, France, 93143
Bordeaux, France, 33000
Creteil, France, 94010
Lille, France, 59037
LYON Cedex 04, France, 69317
Marseille, France, 13005
Nice, France, 06202
Paris, France, 75020
Paris, France, 75571
Rennes Cedex, France, 35062
Toulouse, France, 31059
Vandoeuvre-les-nancy, France, 54500
Villejuif, France, 94800
Germany
Freiburg, Baden-Württemberg, Germany, 79106
München, Bayern, Germany, 81377
München, Bayern, Germany, 81675
Regensburg, Bayern, Germany, 93042
Göttingen, Niedersachsen, Germany, 37075
Hannover, Niedersachsen, Germany, 30625
Aachen, Nordrhein-Westfalen, Germany, 52074
Düsseldorf, Nordrhein-Westfalen, Germany, 40225
Essen, Nordrhein-Westfalen, Germany, 45147
Köln, Nordrhein-Westfalen, Germany, 50937
Mainz, Rheinland-Pfalz, Germany, 55131
Homburg/Saar, Saarland, Germany, 66421
Halle/Saale, Sachsen-Anhalt, Germany, 06120
Magdeburg, Sachsen-Anhalt, Germany, 39120
Berlin, Germany, 12200
Hamburg, Germany, 20246
Greece
Athens / Greece, Greece, 115 27
Larissa, Greece, 41111
Thessaloniki, Greece, 540 07
Hong Kong
Hong Kong, Hong Kong
Hongkong, Hong Kong
Kwun Tong, Hong Kong
Shatin, Hong Kong
Italy
San Giovanni Rotondo, Foggia, Italy, 71013
Bari, Italy, 70124
Benevento, Italy, 82100
Bologna, Italy, 40138
Cagliari, Italy, 09134
Catania, Italy, 95122
Milano, Italy, 20121
Milano, Italy, 20133
Modena, Italy, 41124
Napoli, Italy, 80131
Napoli, Italy, 80123
Padova, Italy, 35128
Palermo, Italy, 90127
Roma, Italy, 00168
Torino, Italy, 10126
Japan
Kashiwa, Chiba, Japan, 277-8577
Kanazawa, Ishikawa, Japan, 920-8641
Kawasaki, Kanagawa, Japan, 213-8587
Yokohama, Kanagawa, Japan, 232-0024
Osakasayama, Osaka, Japan, 589-8511
Suita, Osaka, Japan, 565-0871
Bunkyo-ku, Tokyo, Japan, 113-8655
Chuo-ku, Tokyo, Japan, 104-0045
Itabashi-ku, Tokyo, Japan, 173-8610
Minato-ku, Tokyo, Japan, 105-8470
Shibuya-ku, Tokyo, Japan, 150-8935
Shinjuku-ku, Tokyo, Japan, 162-8666
Fukuoka, Japan, 812-8582
Kumamoto, Japan, 860-8556
Kyoto, Japan, 606-8507
Okayama, Japan, 700-8558
Osaka, Japan, 537-8511
Tokushima, Japan, 770-8503
Korea, Republic of
Daegu, Daegu Gwang'yeogsi, Korea, Republic of, 700721
Goyang-si, Gyeonggido, Korea, Republic of, 411-706
Goyang-si, Gyeonggido, Korea, Republic of, 410-769
Seoul, Seoul Teugbyeolsi, Korea, Republic of, 135-720
Busan, Korea, Republic of, 602-739
Jeollabuk-do, Korea, Republic of, 561-712
Seoul, Korea, Republic of, 110-744
Seoul, Korea, Republic of, 120-752
Seoul, Korea, Republic of, 138-736
Seoul, Korea, Republic of, 135-710
Mexico
Monterrey, Nuevo Leon, Mexico, 64710
México, D.F., Mexico, 14050
México, D.F., Mexico, 14080
New Zealand
Auckland, New Zealand, 1023
Christchurch, New Zealand, 8011
Peru
Chiclayo, Peru, CIX
Lima, Peru, LIMA 11
San Borja, Peru
Portugal
Coimbra, Portugal, 3000-075
Lisboa, Portugal, 1069-166
Romania
Bucharest, Romania, 022326
Bucharest, Romania, 11172
Cluj-Napoca, Romania, 400015
Iasi, Romania, 700106
Iasi, Romania, 700111
Russian Federation
Moscow, Russian Federation, 119992
Moscow, Russian Federation, 115478
Obninsk, Russian Federation, 249036
St. Petersburg, Russian Federation, 197758
Voronezh, Russian Federation, 394000
Singapore
Singapore, Singapore, 169608
Singapore, Singapore, 119228
Spain
Oviedo, Asturias, Spain, 33006
Sabadell, Barcelona, Spain, 08208
Cruces/Barakaldo, Bilbao, Spain, 48903
Barcelona, Catalunya, Spain, 08035
Majadahonda, Madrid, Spain, 28222
A Coruña, Spain, 15006
Badajoz, Spain, 06080
Barcelona, Spain, 08036
Córdoba, Spain, 14004
Madrid, Spain, 28040
Madrid, Spain, 28007
Valladolid, Spain, 47012
Sweden
Göteborg, Sweden, 413 45
Stockholm, Sweden, 141 86
Switzerland
Bern, Switzerland, 3010
Zürich, Switzerland, 8091
Taiwan
Changhua, Taiwan, 500-06
Kaohsiung City, Taiwan, 807
Kaohsung, Taiwan, 833
Tainan, Taiwan, 704
Taipei, Taiwan, 100
Taipei, Taiwan, 112
Taoyuan, Taiwan, 333
United Kingdom
Southampton, Hampshire, United Kingdom, SO16 6YD
Greater Manchester, Manchester, United Kingdom, M20 4BX
Birmingham, West Midlands, United Kingdom, B15 2TT
Leeds, West Yorkshire, United Kingdom, LS9 7TF
London, United Kingdom, SE5 9RS
London, United Kingdom, NW3 2QG
London, United Kingdom, EC1M 6BQ
Newcastle Upon Tyne, United Kingdom, NE7 7DN
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided by Bayer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00692770     History of Changes
Other Study ID Numbers: 12414, 2008-001087-36
Study First Received: June 5, 2008
Last Updated: September 11, 2014
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Brazil: National Health Surveillance Agency
Chile: Instituto de Salud Pública de Chile
Mexico: Federal Commission for Sanitary Risks Protection
Austria: Ethikkommission
Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment
Bulgaria: Bulgarian Drug Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: German Institute of Medical Documentation and Information
Greece: Ethics Committee
Italy: The Italian Medicines Agency
Romania: National Medicines Agency
Russia: Ethics Committee
Switzerland: Swissmedic
Sweden: Ethikkommission
Spain: Spanish Agency of Medicines
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Canada: Health Canada
Australia: Department of Health and Ageing Therapeutic Goods Administration
China: Food and Drug Administration
Japan: National Institute of Health Sciences
Hong Kong: Department of Health
Korea: Food and Drug Administration
New Zealand: Medsafe
Singapore: Health Sciences Authority
Taiwan: Department of Health
United States: Food and Drug Administration

Keywords provided by Bayer:
Hepatocellular carcinoma
Sorafenib
Adjuvant
Surgical resection
Ablation
Nexavar
Adjuvant therapy
Liver cancer
HCC
STORM

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Adenocarcinoma
Digestive System Diseases
Digestive System Neoplasms
Liver Diseases
Liver Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Sorafenib
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Kinase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014